JPRN-jRCT2080220970
Unknown
Phase 1
A Phase 1, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Hormone Therapy-Resistant Prostate Cancer Subjects
ConditionsProstate cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- Takeda Pharmaceutical Company Limited
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria include the following:
- •1\. Japanese patients histologically or cytologically diagnosed with prostate cancer
- •2\. Undergone orchiectomy or receiving hormone therapy with an LH\-RH agonist, with serum testosterone \< 0\.5 ng/mL at screening
- •3\. PSA \=\> 2 ng/mL at screening
- •4\. Increase from nadir PSA in two or more successive measurements before screening\* (The measurements must be made at least one week apart at the same laboratory.)
- •\*Even if the patient's PSA level at the second measurement is not higher than the increased PSA level at the first measurement, he is regarded to meet this criterion if his PSA level at the third measurement is higher than the first increased PSA level.
- •5\. No use of any antiandrogens during a period specified below:
- •1\) Bicalutamide: \=\> 6 weeks (42 days) prior to the first dose of the investigational product
- •2\) Other antiandrogens: \=\> 4 weeks (28 days) prior to the first dose of the investigational product
- •6\. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2 at screening
Exclusion Criteria
- •Exclusion criteria include the following:
- •1\. Prior chemotherapy
- •2\. Prior Estramustine therapy
- •3\. Prior 125I seed implants brachytherapy
- •4\. Use of any of the following therapies for prostate cancer within 16 weeks (112 days) prior to the first dose of the investigational product: high intensity focused ultrasound, prostatectomy, radiation therapy (except 125I seed implants brachytherapy)
- •5\. Use of any of the following within 4 weeks (28 days) prior to the first dose of the investigational product: androgen preparations, estrogen preparations (except estramustine), 5 alpha\-reductase inhibitors (i.e., finasteride, dutasteride), zoledronate, Chinese herbal medicines including Saw Palmetto, and supplements
- •6\. Use of any of the following within 4 weeks (28 days) prior to the first dose of the investigational product: spironolactone and corticosteroids (with the exception of inhaled and topical steroids)
- •7\. Use of any prior therapy for prostate cancer (e.g., ketoconazole \[with the exception of topical formulations]) within 4 weeks (28 days) prior to the first dose of the investigational product
- •8\. Active multiple primary cancers (synchronous multiple primary cancers, or metachronous multiple primary cancers with a disease\-free period of 5 years or less).
- •9\. Past or concomitant adrenal insufficiency
Outcomes
Primary Outcomes
Not specified
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